While dodging black cats, walking under open ladders and looking into broken mirrors, Jay Rosen and myself are back on this Friday the 13thto take a look at some of the top compliance stories from the past week.

  1. Want to take a deep dive into the Credit Suisse FCPA enforcement action? Check out Tom’s 3-blog post series (Part I, Part IIand Part III) and Mike Volkov’s two-part series (underlying factsand lessons learned).
  2. What’s the best way to use data to detect corruption? Enestor Dos Santos, principal economist at BBVA Research writes in Global Anti-Corruption Blog. For the full BBVA Research report clickhere.
  3. Did FCPA enforcement pick up in Q2? William Garrett explores this question in WSJ Risk and Compliance Journal.
  4. Romania’s president removes chief anti-corruption prosecutor. Radu-Sorin Marinas reports in Reuters.
  5. Tony Hayward (yes, that Tony “I want my life back” Hayward) will lead Glencore’s corruption investigation. What could go wrong? Harry Cassin explores in the FCPA Blog. Is Glencore pushing the corruption risk envelope too far? David Pilling opines in the Financial Times. (sub req’d)
  6. Does AI create or simply expose ethical dilimmmas? (Hint-it’s all about the data). Vera Cherepanova explores this question in the FCPA Blog.
  7. The second half thebriberyact.com guys; Richard Kovalevsky QC leaves Chambers to move to Stewart’s. Waithera Junghae reports in GIR. (sub req’d)
  8. Are the administration’s moves against ZTE part of a larger all out trade war strategy against China and/or the rest of the world? Louise Lucas explores this question in the Financial Times. (sub req’d) New management says compliance is the top priority. See report in com.
  9. Tone at the top really does matter. PapaJohn Chairman (and former CEO) resigns from Board after using racial slur in con call with vendor. Vendor fires PapaJohn’s as client. See report in Wall Street Journal.
  10. Uber finally gets a CCO but loses its head of HR. Greg Bensinger and Sadie Gurman report in the WSJon the hire. Bensinger reports on the resignation of the head of HR in WSJas well.
  11. The Red Sox have the best record in baseball at the All-Star break. Can they avoid yet another collapse? Jay and Tom debate.

For more information on how an independent monitor can help improve your company’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

Over this five-part podcast series, I have been taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of healthcare services, the public. I have been joined in this exploration by two individuals at Affiliated Monitors, Inc. (AMI), the sponsor of this series. They were Jesse Caplan, Managing Director of Corporate Oversight, and Catherine Keyes, Vice President of Operations. Today, I conclude the series with Caplan on using independent integrity assessment and monitoring to limit adverse consequences.

Many compliance practitioners in the healthcare space (and those in commercial space) often ask if an independent integrity review and monitoring be helpful where an organization may have reason to believe it has an actual or potential compliance problem but has not yet been subject to an enforcement action or a Corporate Integrity Agreement (CIA)  imposed by the government. There are several reasons this is particularly true in the healthcare space. He noted that the government expects, in fact demands, that healthcare organizations self-report certain types of compliance violations. He provided some examples such as overpayments healthcare providers may have received from the government, or false or fraudulent claims that they have billed the government and certain types of privacy breaches.

Caplan believes that using an independent compliance expert can be useful in dealing with the government enforcement agency and convincing that agency to look more favorably where severe sanctions might otherwise be imposed. An independent integrity monitor can be helpful to a healthcare organization where they may have compliance violations. It can even be true with current healthcare issues such as the opioid crisis and excessive opioid prescribing.

Moreover, this is where an independent integrity monitor can be very useful when the organization thinks they have a problem. A monitor can be brought in to assess the compliance program, make recommendations for improvements and then be available to monitor the remedial recommendations as they are implemented. If an organization makes a self-disclosure or if the government comes and investigates the company, they can use the fact that they have used an independent integrity monitor to assess the compliance program and, equally importantly, themselves and they will continue to use the monitor to ensure continued compliance.

By using an independent integrity assessment, an organization can demonstrate to the government entity that the problems with the company’s compliance regime are not endemic or structural but more of an isolated incident. This can help to provide confidence to the public that they can continue to operate safely and in compliance and provide assurance to the government and regulators that it can continue to participate in the government programs with little fear of having those violations reoccur. This can have a very large impact on what types of action the government or regulator will take.

The bottom line in healthcare regulation is that government enforcement and regulatory agencies would prefer not to exclude important healthcare providers who have compliance issues. Their goal to ensure access to sufficient quality providers is a constant challenge for healthcare policymakers. Regulators generally agree that the best solution is to have providers with compliance issues remediate their problems and implement a sustainable and effective ethical compliance program. By engaging an independent compliance expert and monitor can provide the government with confidence that organization has remediated and will be an effective, compliant participant.

We conclude this episode with a few of Caplan’s thoughts on how an independent integrity monitor could have impacted two matters widely in the public eye. They are the matter of Theranos, Inc. and the opioid crisis. With regards to Theranos, a wide variety of stakeholders could have requested a truly independent come in and assess compliance at the company. It could have been the Board of Directors, the Securities and Exchange Commission (SEC), state or federal healthcare regulators or even third parties who were looking to do joint ventures with the company. Such an assessment might have saved many jobs, investments, careers and reputations.

In the opioid crisis, an independent monitor could have done the assessment around large numbers of drugs being prescribed by one doctor or prescribed to be delivered through one pharmacy. But the analysis could have gone much deeper by focusing on the corporate compliance programs, their implementation and training. It could have also looked at those who spoke up by using the hotline or other internal reporting mechanisms.

All of this means that an independent integrity monitor in the healthcare space can be used in a variety of ways and through a variety of mechanisms.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

In this five-part podcast series, I am taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of health care services, the public. I am joined in this exploration with two individuals at Affiliated Monitors, Inc. (AMI), the sponsor of this series, Catherine A. Keyes, Vice President of Operations, and Jesse Caplan, Managing Director of Corporate Oversight. In this episode, I visit with Keyes to discuss how an independent integrity monitor can be used in non-disciplinary administrative proceedings.

The first scenario is around hospital conversions. Many states have laws in place to protect the public’s interest when a not-for-profit hospital is sold to a for-profit entity. The state’s Attorney General or Department of Health may impose conditions on the new entity, in some cases to prevent it from simply “flipping” the hospital and extracting the dollar value of the goodwill that was invested by the state when it was not-for-profit.

Hospitals started by charitable or religious organizations may have been acquired or approached by for-profit entities who might be interested in acquiring them. States are concerned that they simply want these healthcare institutions snapped up, so the states want to make sure that the interest of the public are really protected. There are multiple interests that the public has when a not-for-profit entity is bought by a for-profit entity; including things like making sure that the for-profit entity will exist as a healthcare provider for a reasonable period of time, they are good neighbors, that they pay taxes and if there were charities that were in place, those charities continue.

When such a conversion occurs, the purchaser may agree to a wide variety of conditions, such maintaining certain services, making capital improvements, expanding in certain areas, meeting certain public health standards (for immunizations, treatment standards, coordination of care) and addressing certain public health priorities, such as opioid overdose risks or area-specific issues like Lyme disease. An independent integrity monitor may engage in some or all of the following: review of money to be sure it is spent according to conditions; review of policies, procedures, contracts, training materials; review of assignment of assets,  e.g. donations that were earmarked for a purpose that is no longer possible; visits to the hospital to see if certain programs are functioning, to see if services are being offered as agreed-upon; interviews with staff to see how medical requirements are being met; and review of charts to see whether processes are being followed. In short there are wide variety of conditions which be in place or which the state or regulators want visibility into and a monitor can provide that visibility.

A monitor can also consider other factors, which may seem to less healthcare related but could impact a conversion. There might be an agreement for capital improvements, for example, there might be total dollar amounts to be invested, dollar amounts per year or there might be dollar amounts over a span of time. It could all depend on what the long-term plans are for the acquirer. As an acquirer typically does not make a lot of capital improvements in the first year, a regulator would need a monitor in place for some period of time to make sure the investments are made and  the money spent is actually going on capital improvements. There could be ancillary agreements such as participation in and sponsoring of community activities or education, all of which need to be monitored.

A monitor can drill down into whether the healthcare provider put out advertisements about those kinds of things and see if the public and the person or persons involved actually attended them. Another area often seen is around charitable assets, where a donor may have made a bequeath to a hospital for a specific purpose. If the specific purpose is no longer available; for instance, if it was for a hospital wing that is getting closed down and not being used for the kind of care that it was set up for, those assets might be reassigned.

A second area could be granting of licenses or Certificate of Need and the conditions that a state may impose. This could be for a new hospital, a renewal or some other healthcare facility where the state really wants to have some continued oversight. Keyes explained that while it is not substantively different than the acquisition realm, it is more quantitatively different. There may be a smaller set of conditions, that have been agreed upon. An example might be a Certificate of Need associated with the purchase of a large piece of equipment which might change the dynamics around a facility.

An independent integrity monitor extends the capability of the state agencies and regulators, it allows them to confirm that the entities are meeting the conditions. A monitor can review the paper trail indicating that the agreed-upon processes are in place and can help to keep a healthcare provider’s compliance program on a schedule, so that it does not slip too far down the list of company priorities.

For more information on how an independent monitor can help improve your company’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

In this five-part podcast series, I am taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of healthcare services, the public. I am joined in this exploration with two individuals at Affiliated Monitors, Inc. (AMI), the sponsor of this series, Catherine A. Keyes, Vice President of Operations, and Jesse Caplan, Managing Director of Corporate Oversight. In this third episode, I visit with Keyes to discuss how an independent integrity monitor can be used in healthcare licensing and disciplinary proceedings.

I started off by asking Keyes about the situation where a state Medicaid Fraud Control Unit finds a provider billing for an unusually high number of patients or procedures per day. Through an investigation, the state unit finds poor documentation that looks like fraud. How can an independent integrity monitor serve as an overall part of a resolution? Keyes noted that initially such a settlement will allow the provider or clinic to continue to practice, which is important for Medicaid providers. Keeping a Medicaid practice open is often very important in some areas, where there are very few Medicaid providers, so having a Medicaid provider remain open is important, not just for the person whose business it is, but also in the community. Keeping or bringing up such a healthcare provider to professional standards is also important. Finally, it is critical all the way around to keeping pressure on the provider to make the promised changes to fix the system and it protects the public by bringing the provider in line with professional standards.

We next discussed the scenario where someone makes a complaint to a licensing board, the complaint is investigated, and the licensing board finds, among other things, that the practitioner’s patient records lack basic elements: for example, adequate notes about treatments. Keyes noted that oftentimes a complaint is made to a state regulatory agency, a licensing board, for example. It might be a dental board, it might be a medical board, it might be a chiropractic board. Most of these licensing boards have regulations that say what minimally should be included in patient records. And this is the standard you would hope that any kind of a medical provider is recording in writing. This is critical  for a patient’s medical care going forward.

Here Keyes believes that an independent integrity monitor can be an excellent option as it allows the healthcare provider to continue to practice while providing prompt feedback to the agency about whether the healthcare provider is making promised changes. This is because a straight suspension may hit the pocketbook without helping the provider make meaningful change.

Yet there is an equal if not greater benefit to the healthcare provider as the independent integrity monitor can provide tailored advice about how to bring the practice up to professional standards. Keyes provided a simple yet straight-forward example, “I once saw the difference between having a chiropractor’s friend act as a monitor and write an overly simplistic report – “the charts look fine” – and the in-depth feedback given by professional monitors: “the history of present illness needs to be more complete, including info about the effectiveness of other treatments received”.”

I asked Keyes about using an approach of an independent integrity monitor in a current situation such as the opioid crisis. She said that such use could allow an independent integrity monitor to track prescriptions and prescribers of opioids and other drugs. She said that as part of a multi-pronged approach to the opioid abuse issue, many states are looking to see who their high prescribers are and whether these are legitimate practices or just pill mills. A monitor can help a provider to put policies and procedures in place to (a) assess the underlying need for pain medication; (b) determine whether someone is actually taking the medications; (c) refer to other specialists for supplemental care: physical therapy, acupuncture, pain clinics; and (d) appropriately terminate care of patients who appear to be getting prescriptions primarily to re-sell the pills.

Yet the benefits do not end there as monitoring, as part of settlement agreement, could require the provider to reduce the number of pain patients and the quantity of pills prescribed over a certain period. An independent integrity monitor can keep the regulators informed as most state agencies do not have the staff available to track compliance with the details of such an agreement. Independent monitoring is paid for by the licensee. Such use of a monitor also works to protect the public by bringing the professional in line with national standards for assessment, treatment and follow-up of pain patients. Finally, using a monitor can allow the provider to remain open and demonstrate their commitment to improved practice. Healthcare providers are quick learners and, in some cases, putting a structured program in place is a relief.

Next up, using monitors in administrative proceedings not related to discipline and licensing issues.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

In this five-part podcast series, I am taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of health care services, the public. I am joined in this exploration with two individuals at Affiliated Monitors, Inc. (AMI), the series sponsor, Catherine A. Keyes, Vice President of Operations, and Jesse Caplan, Managing Director of Corporate Oversight. In this Episode 2, I visit with Jesse Caplan on the significance of proactive assessment in healthcare ethics and compliance program in determining culture.

Caplan noted that not every healthcare participant has a good handle on how effective their compliance program is and whether the culture of the organization is such that compliance risks are likely to be timely identified, mitigated and remediated.  However an independent integrity monitor can help healthcare participants to do a thorough pro-active assessment of a healthcare organization’s ethics and compliance program and culture.

An independent compliance expert can bring a fresh set of eyes to any organization or entity. Such an expert can provide several valuable inputs to any organization including: demonstrating to the Board organization’s ethical culture and effective compliance program; identify gaps or weaknesses in the compliance program when a healthcare organization has a problem, for instance, a compliance problem where the government gets involved; provide recommendations for remediations demonstrate to government regulators the seriousness and effectiveness of the organizations compliance program; educating an organization’s workforce; and, finally, sending a strong positive message throughout the entire organization that they take compliance very seriously and expects the workforce to take it seriously as well.

There are multiple ways to conduct a pro-active assessment of an organization’s ethics and compliance program and AMI selects the style and techniques which best fit the situation. Caplan noted some of these techniques can include areview of applicable policies and procedures, whether the organization has a hotline which is use and compliance training.However, Caplan emphasized such techniques can only get you so far.

This means you need to also perform an assessment of compliance program effectiveness by a variety of mechanisms such as determining if the compliance policies and procedures are effectively implemented, whether staff are familiar with and truly understand their compliance obligations and even whether they feel they can communicate compliance and ethical concerns or questions without fear of adverse consequences.   

We next turned to how to make such an assessment. Here Caplan noted there are several ways to do so. It can include interviews with individual employees, focus groups with larger numbers of employees, visits to not only the corporate headquarters but also remote company locations and, of course, the analysis of all relevant data. He provided an example where AMI would test a hotline and how, when complaints come in, they are actually handled. Such testing would use all these techniques including employee interviews, focus groups meetings and review of data on hotline complaints and case closure rates and data.

A proactive assessment can be used in times simply beyond when an organization may have a reason to believe that it has an ethics or compliance problem. It can be used when there is a change in leadership and the new leadership team wants to see more precisely where they may be on the ethics and compliance scale. It can also be used when there is a major acquisition or a healthcare provider establishes new business units or even goes into new markets.

In some situations an independent evaluation team may be called to work collaboratively with others such as outside counsel. It all starts with the value of the pro-active assessment that they are independent and unbiased which gives them  greater credibility with stakeholders.  However, the organization and evaluation team can and should work collaboratively to develop the work plan and target potential risk areas. There should also be collaboration in deciding findings and recommendations of the assessment to be communicated. All of this helps to provide an independent, unbiased proactive assessment of a compliance and ethics programs and can make the organization stronger and the workforce more engaged in compliance.

One of the key differences in healthcare as opposed to perhaps the energy or tech sector or another commercial enterprise, is that the government and the regulators would prefer not to exclude healthcare providers from the healthcare industry. This means even if a healthcare provider has a compliance issue, the government and regulators may be loathed to deliver an ultimate sanction and put a healthcare provider out of business. Access to quality healthcare providers is a continuing issue within the industry and particularly for government programs like Medicaid. One of the reasons is that not every healthcare provider is willing to participate in Medicaid programs and’ particularly for vulnerable populations, there can be an inadequate number of healthcare providers available to treat those populations. This means from a public policy perspective, whether it is the federal government or state government departments of public health, they all want to have as many quality providers as possible so people and the patients have adequate access to those services.

This can sometimes run up against the tension of healthcare providers in those areas of medical services who have run into difficulties that could pose a threat to patients and the public or could pose a threat to the public financing by misusing or abusing the funds that are being paid. This means that the government or regulators must be comfortable that the problems an organization has have been remediated and will be addressed so that those issues will not arise going forward. If using an independent integrity monitor can help the government by meeting these two objectives of both quality providers and providing sufficient access for its citizens, it is a win for all involved.

Next up, using independent integrity monitoring in licensing and disciplinary proceeding.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.